High flow volume nasal irrigation device and method for alternating pulsatile and continuous fluid flow

ABSTRACT

A high flow volume nasal irrigation device includes a squeeze bottle, a reservoir of liquid and a volume of air. The bottle is configured to elastically deform in response to a manual pressure from a user and thus pressurize the liquid and air. The device also includes a dip tube configured to convey a pressurized liquid flow from a first end inside the bottle to a second outside end at a lower pressure. A removable nipple cap comprises an orifice and a coaxially aligned extension configured to seal with the dip tube and to form a conduit with the tube. At least one air metering orifice is formed in the fluid conduit accessible to the to volume of air. The air metering orifice is configured to introduce a plurality of air pockets from the air volume into the liquid flow and thus generate a pulsatile fluid flow in the conduit.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of the priority date of earlierfiled U.S. Provisional Patent Application Ser. No. 61/278,455, filedOct. 8, 2009 incorporated herein by reference in its entirety.

BACKGROUND

Flood irrigation differs significantly from the practice of inhaling anatomized mist into the nose. During flood irrigation, the vast majority(>95%) of fluid taken in is expelled immediately (or shortly thereafter)after the contaminants have been rinsed out. Rinsing with floodirrigation is commonly performed by ingesting the liquid solution intoone nostril and concurrently expelling the solution from the othernostril. Alternately, flood irrigation is sometimes performed byingesting the liquid solution into both nostrils simultaneously andhaving the excess flow to the mouth. Flood irrigation has beendemonstrated to be more effective than mist for the distribution ofmedications and the physical rinsing of the mucus membranes of the noseand sinuses. A user of nasal flood irrigation may typically use thetechnique once or twice per day as opposed to a user applying a mistseveral to many times a day.

The use of flood irrigation to cleanse, soothe and rehabilitate nasaland sinus passages has a long history which probably began with thepractice of intentional inhalation of sea water from cupped hands. Laterdevices such as the Neti Pot made the practice more practical. Todaythere is a wide array of devices and technologies to facilitate therinsing by flood irrigation of the nasal passages and sinus cavities.Investigation of prior art shows that the number of relevant devices andtechniques has grown at an increasing rate in recent decades and inparticular during the last ten years. This growth in technology hasparalleled the increasing popularity of the practice as the technologyhas become more effective and as the benefits of the practice havebecome more appreciated.

Within the field of flood irrigation for nasal rinsing there aredevelopments in the liquid solutions being used and there aredevelopments in the device which delivers the liquid stream. The liquiddelivery devices for nasal flood irrigation may be generally dividedinto two major commercial categories—a) simple devices which dispense acontinuous low pressure stream of fluid from a squeeze bottle,deformable bulb, bellows container, shower head connection, gravityfeed, etc., and b) devices which use a motorized pump or other complexand expensive electromechanical apparatus to provide a pulsating streamof fluid. Both categories of device have advantages and disadvantages.

The devices which dispense a continuous low pressure stream of irriganttypically are very low in cost and may have advantageously high flowrate capability. Unfortunately, these devices offer a less than optimalcleaning ability due to the tendency of the continuous stream to formlaminar flow paths across the surfaces to be rinsed and due to thesurfaces not being deformed and agitated by the smooth flow stream.These continuous stream devices are also ineffectual in projectingliquid medications or irrigants into sinus cavities because the closedend cavities require time varying pressures to cause fluid entry. Theyalso fail to rehabilitate nasal cilia which have lost motility.

The pulsating electromechanical devices have the advantages of causing amuch more turbulent scouring flow with high shear stress gradients alongthe surfaces, causing a mixing action to reduce surface basedconcentration gradients and deformations of the surfaces being rinsed(for flexible surfaces) and healthy movement of the nasal cilia.Pulsating electromechanical devices unfortunately offer a less thanoptimal flow rate. Additionally, the pulsatile electromechanical devicesare significantly more complex and costly, with purchase costapproximately ten times that of a squeeze bottle irrigator. This highcost prevents many potential users from purchasing them and does notfavor the periodic disposal of the device which is necessary to avoidcolonization by bacteria and molds.

SUMMARY OF THE INVENTION

A high flow volume nasal irrigation device for pulsatile and continuousfluid flow is disclosed. The device includes a chamber having areservoir of liquid and a volume of air. The chamber is configured toelastically deform in response to an applied pressure and thuspressurize the liquid and air therein. The device also includes a fluidconduit configured to convey a pressurized liquid flow from a first endinside the chamber to a second end outside the chamber at a lowerpressure. At least one air metering orifice is formed in the fluidconduit. The air metering orifice is configured to introduce a pluralityof air pockets from the air volume into the liquid flow and thusgenerate a pulsatile fluid flow in the conduit.

A disclosed high flow volume nasal irrigation device allows a user toalternate pulsatile and continuous fluid flow. The device may alsoinclude a squeeze bottle with an open end, a reservoir of liquid and avolume of air. The squeeze bottle is configured to elastically deform inresponse to a manual pressure from a user and thus pressurize the liquidand air. The device also includes a dip tube configured to convey apressurized liquid flow from a first end inside the squeeze bottle to asecond end outside the squeeze bottle. The second end comprises a voidin the tube wall. A removable nipple cap is also included, the capconnected to the squeeze bottle open end. The cap comprises a nippleorifice and a coaxially aligned cylindrical socket configured torotatably seal with the dip tube second end to form a conduit with thetube. An air channel is formed axially and adjacent to the cap socket.The air channel and the second end void together are configured to forman air metering orifice when rotatably aligned to introduce a pluralityof air pockets into the fluid flow from the air volume and thus generatea pulsatile fluid flow.

A high flow volume nasal irrigation device for pulsatile and continuousfluid flow may include the squeeze bottle as configured above. Thedevice may also include a dip tube configured to convey a pressurizedliquid flow from a second end outside the squeeze bottle to a first endinside the squeeze bottle configured to extend into the reservoir ofliquid. The device may also include a removable cap disposed on thesqueeze bottle open end. The cap comprises a nipple end and an opposingcoaxial extension where the extension comprises an externally threadedchannel and is configured to seal to the tube inside diameter. Thenipple end of the cap comprises a tube stop and an orifice. An airmetering orifice is formed at a mouth of the externally threaded channelin a hollow area above the tube stop accessible to the volume of air tointroduce a plurality of air pockets into the fluid flow and thusgenerate a pulsatile fluid flow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevational view of a high flow volume nasal irrigationdevice for alternating pulsatile and continuous fluid flow in accordancewith an to embodiment of the present disclosure.

FIG. 2 is a partial sectional view through the cap of the device inaccordance with an embodiment of the present disclosure.

FIG. 3 is a cross-sectional view through the cap and bottle including asectional view of the tube in accordance with an embodiment of thepresent disclosure.

FIG. 4 is a perspective view of one end of the dip tube showing detailof an air metering orifice in accordance with an embodiment of thepresent disclosure.

FIG. 5 is an elevational view through the bottle showing an alternateposition of the dip tube configurable by a user in accordance with anembodiment of the present disclosure.

FIG. 6 is a view of the cap and dip tube configured as a nasal adapterfor an external pump in accordance with an embodiment of the presentdisclosure.

FIG. 7 is a sectional view of the device comprising a rotatable tubeconfigured to adjust the size of an air metering orifice in conjunctionwith the cap in accordance with an embodiment of the present disclosure.

FIG. 8 is an enlarged view of the cap depicting the interface betweenthe cap and the dip tube to produce a variable air metering orifice inaccordance with an embodiment of the present disclosure.

FIG. 9 is a sectional view through the top diameter of the cap showingan air passage through the cross section 9-9 of FIG. 8 in accordancewith an embodiment of the present disclosure.

FIG. 10 is a perspective view of the second end of the dip tube showingdetail of a beveled end of the dip tube in accordance with an embodimentof the present disclosure.

FIG. 11 is a sectional view of a dip tube and a cap comprising an airmetering orifice in accordance with an embodiment of the presentdisclosure.

FIG. 12 is a detail of the cap, dip tube and air metering orificethrough the cross section 12-12 of FIG. 11 in accordance with anembodiment of the present disclosure.

FIG. 13 is a sectional view of a high flow nasal irrigation device forto alternating pulsatile and continuous fluid flow including a threadedair channel in accordance with an embodiment of the present disclosure.

Throughout the description, similar or same reference numbers may beused to identify similar or same elements depicted in multipleembodiments. Although specific embodiments of the invention have beendescribed and illustrated, the invention is not to be limited to thespecific forms or arrangements of parts so described and illustrated.The scope of the invention is to be defined by the claims appendedhereto and their equivalents.

DETAILED DESCRIPTION

The shear forces, momentum, and solvency of pulsatile nasal irrigationentrains mucus and contaminants and removes them from bodily cavities.Pulsatile nasal irrigation of the nose and sinus cavities with seawater, saline solution, liquid medications, and similar liquids is a wayto reduce sinus irritation, congestion, and particularly the allergensthat cause allergic rhinitis. Pulsatile nasal irrigation is alsobeneficial after certain surgical procedures, in treating sinusinfections, and other medical conditions.

The present disclosure is a unique and non-obvious nasal floodirrigation device which provides superior cleaning action at a costcomparable to and competitive with the lowest cost current technologyrinsing devices. The disclosed device provides: a) a liquid flow ratehigher than any other known nasal irrigator, b) pulsatile irrigationwhen desired by the user and c) minimal cost. Higher flow rates createhigher Reynolds numbers and therefore more turbulent liquid flow andbetter dilution and suspension of contaminants. Pulsatile irrigationdivides the liquid stream into a series of individual packets of liquidwhich impact the surface to be cleansed with a splattering action and ata velocity greater than that expected of a continuous stream of liquidexpelled under the same conditions. Cost is minimized as the deviceconsists of a very inexpensively modified version of the least expensiveof the known types of high volume nasal irrigation devices: the squeezebottle or similar hand compressed devices.

Embodiments of the disclosed device may comprise a deformable bottleinitially filled by the user to a predetermined level with the desiredrinsing liquid. Above the predetermined level there is intentionallytrapped a to predetermined volume of air. The bottle has at its top acap which includes a nipple orifice at the top to seal against a nostriland a nipple extension at its bottom to attach to a pickup tube whichextends to the bottom of the bottle. Therefore, the cap is also known asa nipple cap herein. An air metering orifice extends through the wall ofthe pickup tube near the top of the pickup tube. Through the airmetering orifice, the air in the upper portion of the bottle (when heldupright) is intermittently allowed to intersperse with the liquidflowing up the pickup tube. This occurs because the air is pressurizedto the some pressure as the water when the sides of the bottle aredeflected inward. When in operation the air alternates with the liquidwithin the diameter of the pickup tube above the orifice and up throughthe dispensing orifice. The total volume of the stream exiting thedevice is dependent on the diameter an internal passage or conduitcomprising a pickup tube, cap, and dispensing orifice. This conduit islarge enough so that the contents of the bottle may be emptied inapproximately 8 seconds at normal squeeze pressure. The resultinginternal passages are approximately 4.5 mm in diameter to achieve this.

During operation, the bottle is compressed to elevate the pressure ofboth the water and air (nearly equally) within the bottle relative tothe dispensing orifice. Water from the bottom of the bottle is urged upthe pickup tube by the pressure difference between the liquid intakeopening at the bottom of the pickup tube and the dispensing orifice atthe top of the cap.

Reference will now be made to exemplary embodiments illustrated in thedrawings and specific language will be used herein to describe the same.It will nevertheless be understood that no limitation of the scope ofthe disclosure is thereby intended. Alterations and furthermodifications of the inventive features illustrated herein andadditional applications of the principles of the inventions asillustrated herein, which would occur to one skilled in the relevant artand having possession of this disclosure, are to be considered withinthe scope of the invention.

FIG. 1 is an elevational view of a high flow volume nasal irrigationdevice for alternating pulsatile and continuous fluid flow in accordancewith an embodiment of the present disclosure. The device as depictedincludes a chamber 1, a cap 2, a dip tube 3, a volume of air 4, a fluidline 5, a reservoir of liquid 6, a to nipple orifice 7, an air meteringorifice (not shown) and a fluid intake opening 11. The chamber 1, alsoknown as a squeeze bottle herein, is configured to elastically deform inresponse to an applied pressure and thus pressurize the liquid 6 and air4 therein. The device also includes a fluid conduit comprising the diptube 3 and the cap 2 together configured to convey a pressurized liquidflow from a first end 11 inside the chamber 1 to a second end connectedto the cap 2 outside the chamber 1 at a lower pressure. An insidenominal diameter of the dip tube 3 may be 4.5 mm (0.180 inches) with acorresponding cross sectional area of 15.9 mm² (0.025 inches²). Aninside maximum diameter of the dip tube 3 may be 7.0 mm (0.280 inches)with a corresponding cross sectional area of 38.5 mm² (0.060 inches²).An inside minimum diameter of the dip tube 3 may be 2.0 mm (0.080inches) with a corresponding cross sectional area of 3.1 mm² (0.005inches²). The circumferential fluid line 5 and indicia placed externallyon the bottle 1 indicate a minimum ratio of liquid 6 to air 4 to producethe pulsatile fluid flow in the conduit for a first squeeze of thebottle 1 by a user.

Embodiments of the present disclosure include a screw-on cap 2 with anupper surface adapted to fit sealingly against a user's nostril. Theunderside of the screw-on cap may engage an elastomeric pickup tube 3through a press fit interface. The pickup tube 3 may extend nearly tothe bottom of the deformable plastic bottle 1, leaving a large enoughgap to the bottom of the bottle 1 so that there is no significant flowrestriction through the tube 3. The bottle 1 includes a painted or inkedhorizontal line 5 on its exterior to indicate an initial liquid 6 level.This level is significant for two reasons: 1) the liquid solution 6 maybe prepared by mixing water (or other liquid) with a pre-measuredsolute. In this case the line 5 serves to control the quantity of liquid6 so that the resulting solution has the desired concentration. 2) Theline 5 serves to control the ratio of the air volume 4 to the volume ofthe liquid solution 6. This ratio should closely correspond to thevolume ratio exiting the device (which is based on the relation betweenthe liquid flow area and an air metering orifice). In this view, arelatively large volume of air at the top of the bottle is readilyapparent.

FIG. 2 is a partial sectional view through the cap of the device inaccordance with an embodiment of the present disclosure. The viewincludes the chamber 1, the cap 2, the dip tube 3, the volume of air 4,the nipple orifice 7, a nipple extension 8, an air metering orifice 9and a threaded connection 10. At least one air metering orifice 9 isformed in the dip tube 3 section of the fluid conduit as shown so as tobe accessible to the volume of air 4 inside the bottle 1. Less thanthree air metering orifices may be comprised in the dip tube and thecap. The air metering orifice 9 is therefore configured to introduce aplurality of air pockets from the air volume 4 into the liquid flow fromthe reservoir of liquid (not shown) and thus generate a pulsatile fluidflow in the conduit starting at the air metering orifice 9 andcontinuing to and out through the nipple orifice 7. The threadedconnection 10 between the bottle and the cap forms a fluid tight seal tomaintain the internal pressure in the bottle resulting from a usersqueezing the bottle or any other action on the bottle creating pressuretherein.

The disclosed device may include embodiments having a cap 2 and adispensing orifice 7 at its top through which a fluid stream exits thedevice into the nostril. The cap 2 is sealingly attached to thedeformable bottle 1 by a threaded connection 10 during immediate use.The position of the metering orifice 9 may be vertically located so thatit will be as high as possible along the length of a pickup tube 3 toavoid the admittance of liquid when the bottle is held at an angle ormoved in a manner that causes sloshing. However, the air meteringorifice 9 may not be so high that its internal surface is obstructed byits attachment to the screw on cap 2 under any adverse condition ofproduction tolerance.

FIG. 3 is a cross-sectional view through the cap and bottle including asectional view of the tube in accordance with an embodiment of thepresent disclosure. The view therefore includes the chamber 1, the cap2, the dip tube 3, the volume of air 4, the nipple orifice 7, the nippleextension 8, the air metering orifice 9 and the threaded connection 10.The cap includes the nipple extension 8 opposite the nipple orifice 7.The nipple extension 8 is configured to be received into and form a sealwith the inside wall of the dip tube 3. An inside nominal diameter ofthe nipple orifice 7 may be 4.5 mm (0.180 inches) with a correspondingcross sectional area of 15.9 mm² (0.025 inches²). An inside maximumdiameter of the nipple orifice may be 7.0 mm (0.280 inches) with acorresponding cross sectional area of 38.5 mm² (0.060 inches²). Aninside minimum diameter of the nipple orifice may be 2.0 mm (0.080inches) with a corresponding cross sectional area of 3.1 mm² (0.005inches²). The cross sectional area of the nipple extension 8 of theorifice may also be of similar diameter and area.

In embodiments, the air metering orifice 9 may be formed in a materialseparate from the conduit in order to more precisely control forming theair metering orifice 9 in which case the separate air metering orificeis configured to fit into the wall of the conduit within the bottle 1.The separate air metering orifice may be configured to fit into theconduit via threads, barbs, flanges and the like formed in at least oneof the conduit and the separate material. Furthermore, the fluid flowconduit may comprise a plurality of air metering orifices 9 and aplurality of plugs. Each of the plugs may be configured to seal at leastone of the air metering orifices 9 allowing less than the three to beopen during use of the high flow volume nasal irrigator device toproduce a pulsatile flow.

Additional embodiments include a nipple extension 8 protruding downwardfrom the main body of cap 2 to sealingly connect to a pickup tube 3 by alight press fit. Thus, an air metering orifice 9 in the tube 3 providesa continuously open air passage between the upper portion of air volume4 (within cap 2) and the interior of the pickup tube 3.

FIG. 4 is a perspective view of one end of the dip tube showing detailof an air metering orifice in accordance with an embodiment of thepresent disclosure. The perspective view depicts the dip tube 3 and theair metering orifice 9. An inside nominal diameter of the air meteringorifice 9 may be 1.25 mm (0.050 inches) with a corresponding crosssectional area of 1.2 mm² (0.002 inches²). An inside maximum diameter ofthe air metering orifice 9 may be 1.8 mm (0.070 inches) with acorresponding cross sectional area of 2.5 mm² (0.004 inches²). An insideminimum diameter of the air metering orifice 9 may be 1.0 mm (0.040inches) with a corresponding cross sectional area of 0.78 mm² (0.001inches²). The air metering orifice 9 is placed proximal to the secondend of the dip tube in order to be accessible to the volume of air (notshown) during a squeeze of the bottle 1. However, an alternativeplacement of the dip tube 3 in relation to the cap 2 and the bottle 1(not shown) may produce differing results.

FIG. 5 is an elevational view through the bottle showing an alternateposition of the dip tube configurable by a user in accordance with anembodiment of the present disclosure. The partial section includes allof the elements of FIG. 1 but depicts the dip tube 3 configured in aninverted position with respect to the cap 2. Therefore, a first end ofthe tube 3 connects to the cap 2 and the tube 3 second end extends intothe reservoir of liquid 6. This configuration allows a user to submergethe air metering orifice 9 into the liquid 6 and allow the user of thedevice to produce a continuous liquid stream from the reservoir 6uninterrupted by the introduction of air pockets from the air volume 4.However, once the liquid 6 level falls below the air metering orifice 9the remaining liquid 6 may be unavoidably expelled in a pulsatilestream.

FIG. 6 is a view of the cap and dip tube configured as a nasal adapterfor an external pump in accordance with an embodiment of the presentdisclosure. In the embodiment depicted, the dip tube 3 and connected cap2 are removed from the bottle 1 (not shown) and a first end of the diptube 3 is connected to a power operated oral irrigator. A user's fingeris placed over the air metering orifice 9 in order to modulate thestrength of the flow stream provided to the nose by controlling the airmetering orifice 9 with a finger as needed.

FIG. 7 is a sectional view of a device comprising a rotatable tubeconfigured to adjust the size of an air metering orifice in conjunctionwith the cap in accordance with an embodiment of the present disclosure.The view depicted includes the bottle 1, a cap 2, a dip tube 3, thevolume of air 4, the horizontal line 5, the reservoir of liquid 6, thenipple orifice 7, the threaded connection 10, the tube first end orfluid intake opening 11, the tube second end 12 and the socket 14. Thedip tube 3 thus configured conveys a pressurized liquid flow from thefirst end 11 inside the squeeze bottle 1 to a second end 12 outside thesqueeze bottle 1. The second end comprises a void such as a gap, anotch, a bevel and any other void in the tube wall. A bevel serving asthe void in the second end extends near the axial center or diameter ofthe tube end 12 to its circumference at an acute angle shown in detailin FIG. 10 below. The removable cap 2 disposed on the squeeze bottle 1open end comprises the nipple orifice 7 and a coaxially alignedcylindrical socket 14 configured to rotatably seal with the dip tube 3second and beveled end 12 to form a conduit extending from the tube 3through the nipple orifice 7. An air channel 15 is formed in the cap 2axially and immediately adjacent to the cap socket 14. The air channel15 and the bevel are configured to form an effective air meteringorifice when rotatably aligned to each other. The resulting air meteringorifice thus in communication with the volume of air 4 may introduce aplurality of air pockets into the fluid flow and generate a pulsatilefluid flow at the nipple orifice 7. The circumferential fluid line 5 andindicia placed externally on the bottle 1 indicate a minimum ratio ofliquid 6 to air 4 to produce the pulsatile fluid flow in the dip tube 3for a first squeeze of the bottle 1 by a user.

By adjusting the size of the air metering orifice 9 relative to thediameter of the internal liquid passage the device may be tailored togive a wide range of pulsatile frequencies. Increases in the airmetering orifice size may decrease the pulsatile frequency. In additionto varying the frequency the ratio of the air metering orifice 9 to theinternal liquid passage may also determine the overall ratio of air toliquid that is dispensed from the dispensing or nipple orifice 7. An airmetering orifice 9 which is too small may not generate pulsatile flowbut may simply create bubbles in the continuous liquid stream. An airmetering orifice 9 which is too large may admit so much air thatcleaning action is reduced and the flow stream becomes uncomfortable tothe user. Experimentation with devices having 4.5 mm diameter liquidpassages have shown that the best air metering orifice 9 sizes areapproximately 1.25 mm diameter with a range of 1.0 mm to 1.8 mm beingjudged to be acceptable. The pulsation frequency may be ˜500-1000 cyclesper minute under these parameters.

FIG. 8 is an enlarged view of the cap depicting the interface betweenthe cap and the dip tube to produce a variable air metering orifice inaccordance with an embodiment of the present disclosure. The view thusdepicted includes all of the elements of FIG. 7 with the exception ofthe reservoir of liquid 6. An intentional and variable alignment of thedip tube 3 second and beveled end 12 and the air channel 15 producevariable size and variable length air pockets in the fluid flow at thediscretion of the user. The user may thus ‘dial in’ effective airmetering orifices in order to achieve a desired pulse at the nippleorifice 7. A non-alignment of the second and beveled end 12 and the airchannel 15 produces a continuous fluid flow at the nipple orifice 7. Thecross section given in FIG. 8 by the line 9-9 is illustrated in FIG. 9and explained below.

FIG. 9 is a sectional view through the top diameter of the cap showingan air passage through the cross section 9-9 of FIG. 8 in accordancewith an embodiment of the present disclosure. The depicted view includesboth an unsectioned portion and a sectioned portion of the cap 2, thesecond end of the dip tube 3 and bevel 16 and the air channel 15. Thetube 3 may thus be intentionally rotated within the socket 12 of the cap2 by a user until the bevel 16 no longer aligns with or faces the airchannel 15 and air flow is shut off.

FIG. 10 is a perspective view of the second end of the dip tube showingdetail of a beveled end of the dip tube in accordance with an embodimentof the present disclosure. The present view details the bevel 16starting near the diameter of the tube second end 12 to itscircumference at an acute angle. The angle depicted approximates 33degrees but larger angles may also be employed. However, the second endmay also comprise a void such as a gap, a notch or any other void in thetube wall which may be used to align with the cap air channel 15 andeffectuate the air metering orifice 9.

FIG. 11 is a sectional view of a dip tube and a cap comprising an airmetering orifice in accordance with an embodiment of the presentdisclosure. The depiction includes the bottle 1, the cap 2, the dip tube3, the volume of air 4, the nipple orifice 7, the threaded connection10, the socket 14, an extended air channel 17 and an air meteringorifice 18. The extended air channel 17 is formed axially andimmediately adjacent to the cap socket 14 but further extends beyond thedip tube 3 towards the nipple orifice 7 to form a fixed air meteringorifice 18 therein independent of the rotation of the dip tube 3. Thecross section given in FIG. 11 by the line 12-12 is illustrated in FIG.12 and explained below.

FIG. 12 is a detail of the cap, dip tube and air metering orificethrough the cross section 12-12 of FIG. 11 in accordance with anembodiment of the present disclosure. The depiction includes the cap 2,the dip tube 3 and the extended air channel 17. The extended air channel17 precludes secondary manufacturing operations to the dip tube 3 inorder to produce a pulsatile fluid flow. Single extended air channel 17and an associated single fixed air metering orifice 18 (not depicted)may be accompanied by additional multiple extended air channels andmultiple fixed air metering orifices in embodiments of the discloseddevice to generate further pulsatile fluid flow available to the user.

FIG. 13 is a sectional view of a high flow nasal irrigation device foralternating pulsatile and continuous fluid flow including a threaded airchannel in accordance with an embodiment of the present disclosure. Thedepicted device includes the bottle 1, the cap 2, the dip tube 3, thevolume of air 4, the nipple orifice 7, the nipple extension 8, thethreaded connection 10, a tube stop 19 and an externally threaded airchannel 20. The squeeze bottle 1 comprises an open end, a reservoir ofliquid 6 (not shown) and the volume of air 4. The bottle 1 is configuredto elastically deform in response to a manual pressure from a user andthus pressurize the liquid 6 and air 4. The dip tube 3 is configured toconvey a pressurized liquid flow from a first end 11 in a reservoir ofliquid 6 inside the squeeze bottle 1 to a second end 12 outside thesqueeze bottle 1. The removable cap 2 is disposed on the squeeze bottle1 open end. The cap 2 comprises a nipple orifice 7 end and an opposingcoaxial nipple extension 8, where the nipple extension 8 is configuredto seal to the tube 3 and comprises a threaded channel 20. The nippleorifice 7 end of the cap 2 comprises a tube stop 19 and a nipple orifice7. An air metering orifice is formed at a mouth of the threaded channel20 in a hollow area 21 above the tube stop 19 accessible to the volumeof air 4 to introduce a plurality of air pockets into the fluid flow andthus generate a pulsatile fluid flow. A helix pitch of the threadedchannel 20 may match a helix pitch of the threaded connection 10 on thecap to enable a one-piece injection mold of the cap.

In embodiments of the disclosed device, the nipple extension 8 has onits outside diameter a spiral air channel 20 which may be similar inappearance to an external acme thread. This may give the nippleextension 8 an outside diameter greater than the outside diameter of thenipple extension 8 in other disclosed embodiments. A dip tube 3 havingan inside diameter suitable for a snug fit onto the outside diameter ofnipple extension 8 may be installed over the nipple until it bottomsagainst a tube stop feature 19 molded into the cap 2. The spiral airchannel 20 may allow air to flow from the air volume 4 at the top of thebottle 1 to a point where it could intersperse with the liquid flow atthe bottom of nipple extension 8. Therefore there may be no need for thecore of the injection mold tooling that forms cap 2 to have someelements which are pulled straight off the part and other elements thatare screw rotated off the part. The entire core of the injection moldtool may therefore be one piece when the helix pitch of the spiral airchannel 20 matches the helix pitch of the threads 10 on the base of thecap 2.

An embodied method for operation of the disclosed high flow volume nasalirrigation device for alternating pulsatile and continuous fluid flowmay be as follows. The bottle may be filled to a marked line with eitherpreviously prepared rinsing solution or with water (preferablycomfortably warm). If filled with water the user may add a pre-packagedsoluble mixture resulting in the desired solution when agitated. Theuser may screw the cap onto the bottle and align the dispensing orificewith one of his nostrils and lightly press the cap against the end ofhis nose to obtain a seal. With this connection made and whilepositioned over a sink or other suitable catch basin the user maysqueeze the bottle to force the pulsatile flow into the nose and sinuscavities. Typically, when using the common fluid fill of 8 oz., bestresults are obtained with 3-4 squeezes applied to alternate nostrils,with the nose being blown between squeezes. Air at the top of the bottlemay need to be replenished at intervals unless accommodations are madefor a significantly large volume of air at the top of the bottle (whichis unnecessary, since the cleansing action is best when used asdescribed above). Once the contents have been expended the bottle willneed to be rinsed and stored in a manner that favors drying and reducesthe possibility of contamination.

In addition to the previously disclosed advantages of low cost pulsatileflow leading to improved cleaning action, an air bleed is open betweenthe air volume at the top of the bottle and the atmosphere through theair channel in the cap, the air metering orifice and the nipple orifice.Therefore, a full capped bottle may not inadvertently spill solution outthe top when the bottle is picked up. The excess pressure created whenthe sides of the bottle are lightly squeezed is vented to theatmosphere. Also, it is common for conventional rinsing bottles tooverflow after filling as the warm solution expands the air trapped inthe top of the bottle by heating and humidifying the air. This does nothappen with the disclosed device because the excess air pressure is bledto the atmosphere through the air channel in the cap, the air meteringorifice and the nipple orifice.

What is claimed is:
 1. A high flow volume nasal irrigation device,comprising: a) a squeeze bottle having an open end, a reservoir of aliquid and a volume of air, the squeeze bottle configured to elasticallydeform in response to a manual pressure from a user and thus pressurizethe liquid and the air; b) a dip tube configured to convey a pressurizedliquid flow from a first end inside the squeeze bottle to a second endoutside the squeeze bottle, the second end comprising a void in a tubewall; c) a removable nipple cap disposed on the squeeze bottle open end,the removable nipple cap comprising a nipple orifice and a coaxiallyaligned cap socket configured to rotatably seal with the dip tube secondend to form a conduit with the dip tube; and d) an air channel formedaxially and adjacent to the cap socket, the air channel and the voidconfigured to form an air metering orifice rotatably aligned tointroduce a plurality of air pockets into the pressurized liquid flowfrom the volume of air and thus generate a pulsatile fluid flow.
 2. Thehigh flow volume nasal irrigation device of claim 1, wherein the voidcomprises a bevel extending from adjacent a central radial axis of thedip tube at the second end proximally at an acute angle to an outerperimeter of the dip tube wall.
 3. The high flow volume nasal irrigationdevice of claim 1, wherein the void comprises a gap, a notch, a bevel orany other void in the tube wall.
 4. The high flow volume nasalirrigation device of claim 1, wherein a cross sectional inside area ofthe air metering orifice is variable in relation to an alignment of thedip tube void with the air channel a nominal 1.2 mm² (0.002 inches²), toa maximum cross sectional inside area of 2.5 mm² (0.004 inches²) and toa minimum cross sectional inside area of zero in the event the void isunaligned with the air channel and air flow is shut off to thepressurized liquid flow.
 5. The high flow volume nasal irrigation deviceof claim 1, wherein a variable alignment of the dip tube second end voidand the air channel produce a variable size and a variable length of airpockets introduced into the pressurized liquid flow and a non-alignmentof the void and the air channel produces a continuous liquid flow at thenipple orifice.
 6. The high flow volume nasal irrigation device of claim1, wherein the squeeze bottle comprises a circumferential line and oneor more indicia placed externally on the squeeze bottle to indicate aminimum liquid to air ratio to produce the pulsatile fluid flow in thedip tube for a first squeeze of the bottle by the user.